189
Views
10
CrossRef citations to date
0
Altmetric
Drug Evaluation

Budesonide/formoterol for the treatment of asthma

Pages 1393-1406 | Published online: 02 Mar 2005

Bibliography

  • WORLD HEALTH ORGANIZATION (WHO): Bronchial asthma. Geneva, Switzerland (2000). WHO fact sheet No. 206.
  • WEISS KB, SULLIVAN SD, LYTTLE CS: Trends in the cost of illness for asthma in the United States, 1985-1994.J. Allergy Clin. Immunol (2000) 106:493–499.
  • NATIONAL ASTHMA CAMPAIGN ASTHMA AUDIT: Out in the open. A true picture of asthma in the United Kingdom today. Asthma (2001) 6 (Suppl.) :11.
  • WEISSFLOG D, MATTHYS H, VIRCHOW JC Jr: Epidemiology and costs of bronchial asthma and chronic bronchitis in Germany. Dtsch. Med. Wochenschc (2001) 126:803–808.
  • GIBSON PG, POWELL H, COUGHLAN J et al.: Self-management education and regular practitioner review for adults with asthma. The Cochrane Library Issue 1. Update Software, Oxford (2003).
  • NATIONAL INSTITUTES OF HEALTH: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE: Global Initiative for Asthma. Global strategy for asthma management and prevention. National Institutes of Health: National Heart, Lung, and Blood Institute, Bethesda (Report No. NIH-NHLI 02–3659) (2002).
  • ••The most widely used guidelines for themanagement of asthma. They include definitions of asthma severity, recommend treatment options for maintenance and exacerbations and detail the goals of asthma therapy.
  • BRITISH THORACIC SOCIETY: British guidelines on the management of asthma. Thorax (2003) 58\(Suppl. 1):1–94.
  • ••These are the most recent guidelines for themanagement of asthma.
  • BATEMAN ED, BOUSQUET J, BRAUNSTEIN GL: Is overall asthma control being achieved? A hypothesis-generating study. Ear: Respic J. (2001) 17:589–595.
  • BATEMAN ED, FRITH LF, BRAUNSTEIN GL: Achieving guideline-based asthma control: does the patient benefit? Ear: Respic (2002) 20:588–595.
  • RABE KF, VERMEIRE PA, SORIANO JB, MAIER WC: Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Respic (2000) 16:802–807.
  • ••Results of a survey that highlights howcurrent asthma treatment fails to come close to the standards recommended in international treatment guidelines.
  • STAHL E: Respiratory patients opinion survey (RESPONSE): market research from asthma patients in Europe. Am. J. Respic Crit. Care Med. (2002) 165:A109.
  • STAHL E, HYLAND ME: Unmet needs of asthma patients, and how these are reflected in attitudes to the disease and its treatment. Respic (2002) 20\(Suppl. 38):410s.
  • MORK A-C, VAN GANSE E, OSMAN L et al.: Factors affecting adherence to prescribed asthma treatment. Ear: Respic (2002) 20\(Suppl. 38):580.
  • CHAPMAN KR, WALKER L, CLULEY S, FABBRI L: Improving patient compliance with asthma therapy. Respic Med (2000) 94:2–9.
  • CLARK NM, PARTRIDGE MR: Strengthening asthma education to enhance disease control. Chest (2002) 121:1661–1669.
  • WARNER JO, NASPITZ CK: Third international pediatric consensus statement on the management of childhood asthma. International Pediatric Consensus Group. Pediatr. Pulmonol (1998) 25:1–17.
  • GREENING AP, IND PW, NORTHFIELD M, SHAW G: Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Lancet (1994) 344:219–224.
  • ••A pivotal study demonstrating that addinga long-acting 132-agonist, salmeterol, to bedomethasone therapy provided superior asthma control compared with bedomethasone alone.
  • PAUWELS RA, LOFDAHL CG, POSTMA DA et al.: Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. N Engl. I Med. (1997) 337:1405–1411.
  • ••A key study demonstrating the superiorefficacy of budesonide and formoterol in reducing the risk of exacerbations compared with budesonide alone.
  • O'BYRNE PM, BARNES PJ, RODRIGUEZ-ROISIN R et al.: Low dose inhaled budesonide and formoterol in mild persistent asthma. The OPTIMA randomised trial. Am. I Respic Grit. Care Med. (2001) 164(8 Pt 1):1392–1397.
  • ••This study demonstrates the addedbenefits of adding formoterol to budesonide therapy.
  • KIPS JC, O'CONNOR J, INMAN MD, SVENSON K, PAUWELS RA, O'BYRNE PM: A long-term study of the anti-inflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma. Am. I Respir. Crit. Care Med. (2000) 161:996–1001.
  • PRICE D, DUTCHMAN D, MAWSON A, BODALIA B, DUGGAN S, TODD P: Early asthma control and maintenance with formoterol following reduction of inhaled corticosteroid dose. Thorax (2002) 57:791–798.
  • LINDBLAD T, MALMQVIST GRANLUND K, ROLLWAGE U, TROFAST E: Delivery characteristics of Symbicort Turbuhaler containing both budesonide and formoterol. Am. J. Respir. Crit. Care Med. (2001) 163:A863.
  • AGERTOFT L, PEDERSEN S: Importance of training for correct Turbuhaler use in preschool children. Acta Paediatr. (1998) 87:842–847.
  • STAHL E, RIBEIRO LB, SANDAHL G: Dose response to inhaled terbutaline powder and peak inspiratory flow through Turbuhaler in children with mild to moderate asthma. Pedlar. Pulmona (1996) 22:106–110.
  • ASKING L: AstraZeneca industrial session: dry powder inhaler formulations for combination products: in vitro performance of combination products. J. Aerosol. Med. (2001) 14:502.
  • HVIZDOS KM, JARVIS B: Budesonide inhalation suspension. A review of its use in infants, children and adults with inflammatory respiratory disorders. Drugs (2000) 60:1141–1178.
  • BARTOW RA, BROGDEN RN: Formoterol. An update of its pharmacological properties and therapeutic efficacy in the management of asthma. Drugs (1998) 55:303–322.
  • OLIVIERI D, CHETTA A, DEL DONNO M et al: Effect of short-term treatment with low-dose inhaled fluticasone propionate on airway inflammation and remodeling in mild asthma: a placebo-controlled study. Am. J. Respir. Grit. Care Med. (1997) 155:1864–1871.
  • VLIAGOFTIS H, SCHWINGSHACKL A,MILNE CD et al.: Proteinase-activated receptor-2-mediated matrix metalloproteinase-9 release from airway epithelial cells. I Allergy Clin. Immuna (2000) 106:537–545.
  • MILLER-LARSSON A, JANSSON P, RUNSTROM A, BRATTSAND R: Prolonged airway activity and improved selectivity of budesonide possibly due to esterification. Am. .1. Respir. Crit. Care Med. (2000) 162(4 Pt 1):1455–1461.
  • •This paper provides evidence of, and a rationale for, the long duration of action of budesonide.
  • BUSSE WW, CHERVINSKY P, CONDEMI J et al.: Budesonide delivered by Turbuhaler is effective in a dose-dependent fashion when used in the treatment of adult patients with chronic asthma. I Allergy Clin. Immuna (1998) 101:457–463.
  • ••Evidence for the dose-response relationshipof budesonide.
  • JATAKANON A, KHARITONOV S, LIM S, BARNES PJ: Effect of differing doses of inhaled budesonide on markers of airway inflammation in patients with mild asthma. Thorax (1999) 54:108–114.
  • PEDERSEN S, HANSEN OR: Budesonide treatment of moderate and severe asthma in children: a dose-response study. J. Allergy Clin. Immuna (1995) 95:29–33.
  • JONES AH, LANGDON CG, LEE PS et al: Pulmicort® Turbohaler® once daily as initial prophylactic therapy for asthma. Respir. Med. (1994) 88:293–299.
  • MCFADDEN ER, CASALE TB, EDWARDS TB et al.: Administration of budesonide once daily by means of turbuhaler to subjects with stable asthma. J. Allergy Clin. Immunol (1999) 104:46–52.
  • SHAPIRO GG, MENDELSON LM, PEARLMAN DS: Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids. Ann. Allergy Asthma Immuna (2001) 86:633–640.
  • RINGDAL N, DEROM E, WAHLIN-BOLL E, PAUWELS R: Onset and duration of action of single doses of formoterol inhaled via Turbuhaler. Respir. Med. (1998) 92:1017–1021.
  • ••Demonstrates the dose-responserelationship of formoterol.
  • SEBEROVA E, ANDERSON A: Oxis® (formoterol given by Turbuhaler) showed as rapid an onset of action as salbutamol given by a pMDI. Respir. Med. (2000) 94:607–611.
  • PALMQVIST M, PERSSON G, LAZER L, ROSENBORG J, LARSSON P, LOTVALL J: Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Ear: Respir J. (1997) 10:2484–2489.
  • PALMQVIST M, ARVISSON P, BECKMAN 0, PETERSON S, LOTVALL J: Onset of bronchodilation of budesonide/formoterol versus salmeterol/fluticasone in single inhalers. Pulm. Pharmaca Ther. (2001) 14:29–34.
  • •Evidence for the rapid and sustained effect of budesonide/formoterol compared with fluticasone propionate/salmeterol.
  • GRONNEROD TA, VON BERG A, SCHWABE G, SOLIMAN S: Formoterol via Turbuhaler gave better protection than terbutaline against repeated exercise challenge for up to 12 hours in children and adolescents. Respir. Med. (2000) 94:661–667.
  • EKSTROM T, RINGDAL N, TUKIAINEN P, RUNNERSTROM E, SOLIMAN S: A 3-month comparison of formoterol with terbutaline via Turbuhaler. A placebo-controlled study. Ann. Allergy Asthma Immuna (1998) 81:225–230.
  • EKSTROM T, RINGDAL N, SOBRADILLO V, RUNNERSTROM E, SOLIMAN S: Low-dose formoterol Turbuhaler (ads) b.i.d., a 3-month placebo-controlled comparison with terbutaline (q.i.d.). Respir. Med. (1998) 92:1040–1045.
  • BARNES PJ: Effect of P-agonists on inflammatory cells. I Allergy Clin. Immuna (1999) 104:S10–S17.
  • KORN SH, JERRE A, BRATTSAND R: Effects of formoterol and budesonide on GM-CSF and IL-8 secretion by triggered human bronchial epithelial cells. Ear: Respir J. (2001) 17:1070–1077.
  • SPOELSTRA FM, POSTMA DS, HOVENGA H, NOORDHOEK JA, KAUFFMAN HF: Additive anti-inflammatory effect of formoterol and budesonide on human lung fibroblasts. Thorax (2002) 57:237–241.
  • ZETTERSTROM 0, BUHL R, MELLEM H et al.: Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. Ear: Respir J. (2001) 18:261–268.
  • ••The first study to compare the efficacy andtolerability of budesonide/formoterol with that of the monocomponents budesonide and formoterol delivered via separate inhalers and budesonide alone.
  • AGGARWAL SK, FRITH LJ, HO M et al.: Fluticasone propionate/salmeterol delivered from a single inhaler demonstrates synergistic benefits in asthma. Am. J. Respir. Crit. Care Med. (2003) 167:A890.
  • TAYLOR DR, HANCOX RJ: Interactions between corticosteroids and 13-agonists. Thorax (2000) 55:595–602.
  • BARNES PJ: Scientific rationale for inhaled combination therapy with long-acting f12-agonists and corticosteroids. Eur. Respir: J. (2002) 19:182-191. A comprehensive review of the evidence supporting the superior efficacy of a combination of inhaled corticosteroids and long-acting 132-agonists.
  • MAK JC, NISHIKAWA M, BARNES PJ: Glucocorticoids increase 132-adrenergic receptor transcription in human lung. Am. J. Physiol (1995) 268(1 Pt 1):L41–L46.
  • BARANIUK JM, ALT M, BRODY D et al.: Glucocorticoids induce 132-adrenergic receptor function in human nasal mucosa. Am. J. Respir. Grit. Care Med. (1997) 155:704–710.
  • •This paper suggests an explanation for the proposed synergy between corticosteroids and 132-agonists.
  • ROTH M, JOHNSON PRA, RUDIGERJJ et al.: Interaction between glucocorticoids and 132-agonists on bronchial airway smooth muscle cells through synchronised cellular signalling. Lancet (2002) 360:1293–1299.
  • OLSSON B: Aerosol particle generation from dry powder inhalers - can they equal pressurized metered dose inhalers?' Aerosol Med. (1995) 8\(Suppl. 3):513–519.
  • THORSSON L, EDSBACKER S, KALLEN A, LOFDAHL C-G: Pharmacokinetics and systemic activity of fluticasone via Diskus and pMDI, and of budesonide via Turbuhaler. Br. J. Clin. Pharmacol (2001) 52:529–538.
  • DERENDORF H, HOCHLAUS G, MEIBOHM B, MOLLMANN H, BARTH J: Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J. Allergy Clin. brimunol. (1998) 101(4 Pt 2):S440–S446.
  • EDSBACKER S, ANDERSSON P, LINDBERG C, RYRFELDT A, THALEN A: Metabolic acetal splitting of budesonide. A novel inactivation pathway for topical glucocorticoids. Drug Metal,. Dispos. (1987) 15:412–417.
  • JONSSON G, ASTROM A, ANDERSSON P: Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver. Drug Metal,. Dispos. (1995) 23:137–142.
  • KAISER H, AARONSON D, DOCKHORN R, EDSBACKER S, KORENBLAT P, KALLEN A: Dose-proportional pharmacokinetics of budesonide inhaled via Turbuhaler®. Br: J. Clin. Pharmacol (1999) 48:309–316.
  • SUMMARY OF PRODUCT CHARACTERISTICS: Symbicort. AstraZeneca UK Ltd (2002).
  • KEMP JP, SKONER DP, SZEFLER SJ, WALTON-BROWN K, CRUZ-RIVERA M, SMITH JA: Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children. Ann. Allergy Asthma Immunol (1999) 83:231–239.
  • AKPINARLI A, TURNER A, SARACLARY, SEKEREL BE, KALAYCI 0: Effect of formoterol on clinical parameters and lung functions in patients with bronchial asthma: a randomised controlled trial. Arch. Dis. Child (1999) 81:45–48.
  • BENSCH G, BERGER WE, BLOKHIN BM et al.: One-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma. Ann. Allergy Asthma Immunol (2002) 89:180–190.
  • LALLOO UG, MALOLEPSZY J, KOZMA D et al: Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroids in adults with mild-to-moderate asthma. Chest (2003) 123:1480–1487.
  • TAL A, SIMON G, VERMEULEN JH et al.: Budesonide/formoterol in a single inhaler versus inhaled corticosteroids alone in the treatment of asthma. Pediatr. Pulmonol (2002) 34:342–350.
  • BATEMAN ED, BANTJE TA, GOMES MJ et al.: Budesonide/formoterol in a single inhaler is more effective than fluticasone in moderate persistent asthma. Am. J. Respir. Med. (2003) 2:275–281.
  • CREEMERS JPHM, BANTJE TA, ELIRAZ A, EKSTROM T, BUHL R: Budesonide/formoterol in a single inhaler once or twice daily provides better asthma control than inhaled fluticasone or budesonide alone in patients with moderate, persistent asthma. Eur: Respir: .1. (2002) 20\(Suppl. 38):S387.
  • BUHL R, CREEMERS JPHM, VONDRA V, MARTELLI NA, NAYA IP, EKSTROM T: Once-daily budesonide/formoterol in a single inhaler in adults with moderate persistent asthma. Respir. Med. (2003) 97:323-330. A clinical study demonstrating the efficacy of once-daily dosing of budesonide/formoterol.
  • KUNA P, CHURCHALIN A, RINGDAL N et al.: Low dose single-inhaler budesonide/formoterol administered once-daily is effective in mild asthma. Eur. Respir. (2001) 18\(Suppl. 33):5158.
  • VAN DER WOUDE HJ, BOORSMA M, BERGQVIST PBF et al: More rapid relief of methacholine-induced bronchoconstriction with budesonide/formoterol than salmeterol/fluticasone. Eur. Respir. (2001) 18\(Suppl. 33):S53.
  • VAN DER WOUDE HJ, BOORSMA M, BERGQVIST PBF, AALBERS R: Symbicort® produces relief of dyspnoea in one minute. Am. J. Respir. Grit. Care Med. (2002) 165(Suppl.):A567.
  • PALMQVIST M, IBSEN T, MELLEN A, LOTVALL J: Comparison of the relative efficacy of formoterol and salmeterol in asthmatic patients. Am. J. Respir. Crit. Care Med. (1999) 160:244–249.
  • FOREST A, MORELLI MC, CATENA E: Low-dose budesonide with the addition of an increased dose during exacerbations is effective in long-term asthma control. The Italian Study Group. Chest (2000) 117:440-446. A clinical study demonstrating that additional and frequent (q.i.d.) doses of budesonide at the onset of an asthma exacerbation were beneficial.
  • TATTERSFIELD AE, LOFDAHL C-G, POSTMA DS et al: Comparison of formoterol and terbutaline in moderate asthma. Am. J. Respir: Crit. Care Med. (1999) 159:A636.
  • IND P, HAUGHNEY J, PRICED, ROSEN J-P, KENNELLY J: Managed adjustable dosing of budesonide/formoterol combination provides equivalent asthma control to fixed dosing at a lower overall dose. Eur: Respir: (2002) 20\(Suppl. 38):S396-S397. A randomised, clinical study showing that adjustable dosing with budesonide/formoterol is as effective as fixed dosing, despite a lower overall drug load.
  • IND P, HAUGHNEY J, PRICED, ROSEN J-P, KENNELLY J: 4-month adjustable or fixed maintenance treatment with budesonide/formoterol in a single inhaler reduced symptom severity. Ear. Respic (2002) 20\(Suppl. 38):541.
  • IND P, HAUGHNEY J, ROSEN J-P, KENNELLY J: Managed adjustable dosing of budesonide/formoterol combination is similarly well tolerated to fixed dosing. Ear. Respic (2002) 20\(Suppl. 38):542.
  • PRICE D, HAUGHNEY J, HUTCHINSON J, LLOYD A, PLUMB J: Budesonide/formoterol with an adjustable maintenance plan costs less and is as effective as fixed dosing. Ear. Respic (2002) 20\(Suppl. 38):5397.
  • HAUGHNEY J, PRICE D, ROSEN J-P, KENNELLY J: Adjustable maintenance treatment with budesonide/formoterol combination rapidly improves and maintains quality of life in asthma patients. Ear: Respir. (2002) 20\(Suppl. 38):541–542.
  • OLSSON P, STALLBERG B, EKSTROM T, LINDARCK N, JORGENSEN LA: Adjustable maintenance treatment of asthma with budesonide and formoterol in a single inhaler. Ear. Respic (2002) 20\(Suppl. 38):5397.
  • •Further evidence that budesonide/formoterol adjustable maintenance dosing provides better asthma control than traditional fixed dosing regimens.
  • BUHL R, KARDOS P, BAARE A et al: Symptom-guided adjustable dosing asthma therapy with budesonide and formoterol in a single inhaler - the ATACO study. J. Allergy Clin. Innnunol. (2003) 111:S127.
  • ROSENHALL L, ERICSSON K, BORG S, ANDERSSON F: Healthcare costs are reduced when asthma is treated with budesonide and formoterol in a single inhaler compared with the same medication via separate inhalers. Ear. Respic (2001) 18\(Suppl. 33):S54.
  • ROSENHALL L, BORG S, ANDERSSON F, ERICSSON K: Budesonide/formoterol in a single inhaler (Symbicort9 reduces healthcare costs in the long-term treatment of asthma compared with separate inhalers. Int. Clin. Pract. (In Press).
  • AGERTOFT L, PEDERSEN S: Effect oflong-term treatment with inhaled budesonide on adult height in children with asthma. N Engl. I Med. (2000) 343:1064–1069.
  • •The best study on the long-term side effects of inhaled corticosteroids in children with asthma.
  • SCHREURS AJ, SINNINGHE DAMSTE HE, DE GRAAF CS, GREEFHORST AP: A dose-response study with formoterol Turbuhaler as maintenance therapy in asthmatic patients. Ear. Respic (1996) 9:1678–1683.
  • MEYER RJ: Supplemental new drug application for changes to the pregnancy subsection of the precautions section related to a change in the pregnancy category for Pulmicort Turbuhaler® 'C' to 'B'. AstraZeneca LP US Food and Drug Administration, Department of Health and Human Services (2001).
  • LOT VALL J, PERSSON G, LARSSON P, MARDELL C, ROSENBORG J: Tolerability of inhaled high doses of formoterol and salbutamol in asthmatic patients maintained on twice-daily formoterol 12 lig (9 lig delivered). Ear. Respir. (1997) 19\(Suppl. 25):5103.
  • ROSENBORG J, BENGTSSON T, LARSSON P, BLOMGREN A, PERSSON G, LOTVALL J: Relative systemic dose potency and tolerability of inhaled formoterol and salbutamol in healthy subjects and asthmatics. Ear. Clin. Pharmacol. (2000) 56:363–370.
  • IND P, BORSZORMENYI NAGY G, PIETINALHO A et al.: Formoterol 4.5 µg, used as needed via Turbuhaler was as safe and well tolerated as terbutaline 0.5 mg. Ear. Respir. (1999) 14\(Suppl. 30):5148.
  • TATTERSFIELD A, LOFDAHL C-G, POSTMA DS et al.: Comparison of formoterol and terbutaline for as-needed treatment of asthma: a randomised trial. Lancet (2001) 357:257–261.
  • MALOLEPSZY J, BOSZORMENYI NAGY G, SELROOS 0, LARSSO P, BRANDER R: Safety of formoterol Turbuhaler® at cumulative dose of 90 pg in patients with acute bronchial obstruction. Ear: Respic J. (2001) 18:928–934.
  • ROSENHALL L, HEINIG JH, LINDQVIST A, LEEGAARD J, STAHL E, BERGQVIST PB: Budesonide/formoterol (Symbicort) is well tolerated and effective in patients with moderate persistent asthma. Int. J. Clin. Pract. (2002) 56:427–433.
  • •The most comprehensive study of the safety of budesonide/formoterol so far.
  • ROSENHALL L, STAHL E, HENIG JH, LINDQVIST A, LEEGARD J, BERGQVIST PBF: Health-related quality of life and asthma control in patients treated with budesonide and formoterol in a single inhaler. Ear. Respic J. (2001) 18\(Suppl. 33):545.
  • ANKERST J, PERSSON G, WEIBULL E: Tolerability of high cumulative doses of budesonide/formoterol single inhaler in patients with asthma. Puhn. Pharmacol. Ther. 16(3):147–151.
  • •A clinical study showing that high doses of budesonide/formoterol are well tolerated.
  • SZAFRANSKI W, CUKIER A, RAMIREZ A et al.: Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Ear: Respic J. (2003) 21:74–81.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.